A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-12-10

Brief Summary

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The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.

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Detailed Description

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This study will investigate the effect of preventive treatment with Lu AG09222 on vasodilation, heart rate increase, and headache induced by PACAP and VIP.

Subjects will be randomised to three arms, placebo + saline, placebo + VIP and PACAP, and Lu AG09222 + VIP and PACAP. Subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo + saline

Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose

Placebo + VIP and PACAP

Placebo, 0.9% normal saline, single dose intravenous infusion over 30 minutes

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose

Lu AG09222 + VIP and PACAP

Lu AG09222, single dose intravenous infusion over 30 minutes

Group Type EXPERIMENTAL

Lu AG09222

Intervention Type DRUG

Single dose

Interventions

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Lu AG09222

Single dose

Intervention Type DRUG

Placebo

Single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject has a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit.
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening.

Exclusion Criteria

* The subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the International Headache Society (IHS) International Classification of Headache Disorders 3rd edition (ICHD-3), except tension-type headache.
* The subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes